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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CORTICAL BONE SCR 5.0MM X 38MM; PROSTHESIS, TRAUMA

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ZIMMER BIOMET, INC. CORTICAL BONE SCR 5.0MM X 38MM; PROSTHESIS, TRAUMA Back to Search Results
Catalog Number 814550038
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Patient Problem/Medical Problem (2688)
Event Date 05/26/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02358, 0001825034-2020-02360, 0001825034-2020-02361.Concomitant medical products: part#: 814509180, lot#: 661770.Part#: 814510115, lot#: vk1121315c.Part#: 814501105, lot#: th1211305c.Part#: 903003004, lot#: unk.Part#: 211201505, lot#: unk.Part#: 211201405, lot#: unk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is not available to be returned per hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that the initial surgery was approximately two (2) months ago.At the three (3) week check-up, surgeon was satisfied with follow up films.Approximately one (1) month post-implantation, obese patient fell and apparently "hobbled" on it for five (5) days before being removed.All implants were intact.Surgeon implanted a total hip because the lag screw penetrated through the femoral head (ie.Cut out).
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.It was reported the lag screw penetrated through the femoral head and all other implants remained intact.The initial report was forwarded in error and should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
CORTICAL BONE SCR 5.0MM X 38MM
Type of Device
PROSTHESIS, TRAUMA
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10153506
MDR Text Key196201551
Report Number0001825034-2020-02359
Device Sequence Number1
Product Code HSB
UDI-Device Identifier00887868039492
UDI-Public(01)00887868039492
Combination Product (y/n)N
PMA/PMN Number
K111444
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 10/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number814550038
Device Lot NumberM18817A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/26/2020
Initial Date FDA Received06/15/2020
Supplement Dates Manufacturer Received10/12/2020
Supplement Dates FDA Received10/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberNI
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age59 YR
Patient Weight126
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